| | Class 2 Device Recall Pilling Wecksorb Neurosponges |  |
| Date Initiated by Firm | May 07, 2026 |
|---|
| Date Posted | July 01, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2639-2026 |
|---|
| Recall Event ID |
98962 |
| 510(K)Number | K791871 |
|---|
| Product Classification |
Gauze/sponge, internal - Product Code EFQ
|
| Product | Brand Name: Pilling Wecksorb
Product Name: Pilling Wecksorb Neurosponges (Cotton)
Pilling Wecksorb Neurosponge Strips (Cotton)
Model/Catalog Number:
200100
200101
200102
200103
200104
200105
200106
200108
200110
200112
200120
200121
200123
200131
Software Version: N/A
Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues.
Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision.
Component: N/A |
|---|
| Code Information |
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1/2" X-Ray Detectable
Catalog Number: 200100
UDI codes:
(01)2 4026704 41748 7(17)260521(11)210521(10)21E1485
(01)2 4026704 41748 7(17)260811(11)210811(10)21H2304
(01)2 4026704 41748 7(17)260906(11)210906(10)21H2594
(01)2 4026704 41748 7(17)260906(11)210906(10)21H2595
(01)2 4026704 41748 7(17)261018(11)211018(10)21K3161
(01)2 4026704 41748 7(17)261130(11)211130(10)21L3593
(01)2 4026704 41748 7(17)270203(11)220203(10)22A0175
(01)2 4026704 41748 7(17)270316(11)220316(10)22C0661
(01)2 4026704 41748 7(17)270512(11)220512(10)22E1386
(01)2 4026704 41748 7(17)270915(11)220915(10)22J2777
(01)2 4026704 41748 7(17)271019(11)221019(10)22K3102
(01)2 4026704 41748 7(17)271027(11)221027(10)22K3269
(01)2 4026704 41748 7(17)271031(11)221031(10)22K3270
(01)2 4026704 41748 7(17)280124(11)230124(10)23A0102
(01)2 4026704 41748 7(17)280405(11)230405(10)23D0796
(01)2 4026704 41748 7(17)280426(11)230426(10)23D0900
(01)2 4026704 41748 7(17)280530(11)230530(10)23E1180
(01)2 4026704 41748 7(17)280809(11)230809(10)23H1834
(01)2 4026704 41748 7(17)290319(11)240319(10)24C0647
(01)2 4026704 41748 7(17)290522(11)240522(10)24E1133
(01)2 4026704 41748 7(17)290729(11)240729(10)24G1865
(01)2 4026704 41748 7(17)290731(11)240731(10)24G1864
(01)2 4026704 41748 7(17)291112(11)241112(10)24K2820
Lot/Batch Numbers:
21E1485
21H2304
21H2594
21H2595
21K3161
21L3593
22A0175
22C0661
22E1386
22J2777
22K3102
22K3269
22K3270
23A0102
23D0796
23D0900
23E1180
23H1834
24C0647
24E1133
24G1865
24G1864
24K2820
Pilling¿ Wecksorb Neurosponges (Cotton), 1" x 1" X-Ray Detectable
Catalog Number: 200101
UDI codes:
(01)2 4026704 41749 4(17)260520(11)210520(10)21E1503
(01)2 4026704 41749 4(17)260531(11)210531(10)21E1546
(01)2 4026704 41749 4(17)260907(11)210907(10)21H2596
(01)2 4026704 41749 4(17)261019(11)211019(10)21K3162
(01)2 4026704 41749 4(17)261130(11)211130(10)21L3594
(01)2 4026704 41749 4(17)270304(11)220304(10)22B0456
(01)2 4026704 41749 4(17)270317(11)220317(10)22C0677
(01)2 4026704 41749 4(17)270506(11)220506(10)22D1299
(01)2 4026704 41749 4(17)271031(11)221031(10)22K3271
(01)2 4026704 41749 4(17)280201(11)230201(10)23A0103
(01)2 4026704 41749 4(17)280602(11)230602(10)23E1235
(01)2 4026704 41749 4(17)280810(11)230810(10)23H1835
(01)2 4026704 41749 4(17)290730(11)240730(10)24G1863
(01)2 4026704 41749 4(17)290821(11)240821(10)24H2070
(01)2 4026704 41749 4(17)291114(11)241114(10)24K2821
Lot/Batch Numbers:
21E1503
21E1546
21H2596
21K3162
21L3594
22B0456
22C0677
22D1299
22K3271
23A0103
23E1235
23H1835
24G1863
24H2070
24K2821
Pilling¿ Wecksorb Neurosponges (Cotton), 1" x 3" X-Ray Detectable
Catalog Number: 200102
UDI codes:
(01)2 4026704 41750 0(17)260513(11)210513(10)21E1397
(01)2 4026704 41750 0(17)260529(11)210529(10)21E1547
(01)2 4026704 41750 0(17)260907(11)210907(10)21H2597
(01)2 4026704 41750 0(17)261213(11)211213(10)21M3732
(01)2 4026704 41750 0(17)270321(11)220321(10)22C0720
(01)2 4026704 41750 0(17)270509(11)220509(10)22D1297
(01)2 4026704 41750 0(17)270914(11)220914(10)22J2778
(01)2 4026704 41750 0(17)271101(11)221101(10)22K3272
(01)2 4026704 41750 0(17)271103(11)221103(10)22K3273
(01)2 4026704 41750 0(17)280201(11)230201(10)23A0104
(01)2 4026704 41750 0(17)280602(11)230602(10)23E1236
(01)2 4026704 41750 0(17)280913(11)230913(10)23J2156
(01)2 4026704 41750 0(17)290501(11)240501(10)24D0986
(01)2 4026704 41750 0(17)290801(11)240801(10)24G1867
(01)2 4026704 41750 0(17)291031(11)241031(10)24K2761
(01)2 4026704 41750 0(17)291118(11)241118(10)24K2822
Lot/Batch Numbers:
21E1397
21E1547
21H2597
21M3732
22C0720
22D1297
22J2778
22K3272
22K3273
23A0104
23E1236
23J2156
24D0986
24G1867
24K2761
24K2822
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1 1/2" X-Ray Detectable
Catalog Number: 200103
UDI codes:
(01)2 4026704 41751 7(17)260514(11)210514(10)21E1398
(01)2 4026704 41751 7(17)260520(11)210520(10)21E1504
(01)2 4026704 41751 7(17)260812(11)210812(10)21H2305
(01)2 4026704 41751 7(17)260909(11)210909(10)21H2599
(01)2 4026704 41751 7(17)261001(11)211001(10)21H2598
(01)2 4026704 41751 7(17)261019(11)211019(10)21K3163
(01)2 4026704 41751 7(17)261213(11)211213(10)21M3733
(01)2 4026704 41751 7(17)270304(11)220304(10)22B0457
(01)2 4026704 41751 7(17)270420(11)220420(10)22D1035
(01)2 4026704 41751 7(17)270608(11)220608(10)22D1298
(01)2 4026704 41751 7(17)271107(11)221107(10)22K3274
(01)2 4026704 41751 7(17)280202(11)230202(10)23A0105
(01)2 4026704 41751 7(17)280425(11)230425(10)23D0901
(01)2 4026704 41751 7(17)280605(11)230605(10)23E1237
(01)2 4026704 41751 7(17)280807(11)230807(10)23H1836
(01)2 4026704 41751 7(17)290502(11)240502(10)24D0987
(01)2 4026704 41751 7(17)290726(11)240726(10)24G1868
(01)2 4026704 41751 7(17)290822(11)240822(10)24H2072
(01)2 4026704 41751 7(17)290822(11)240822(10)24H2073
(01)2 4026704 41751 7(17)291116(11)241116(10)24K2823
Lot/Batch Numbers:
21E1398
21E1504
21H2305
21H2599
21H2598
21K3163
21M3733
22B0457
22D1035
22D1298
22K3274
23A0105
23D0901
23E1237
23H1836
24D0987
24G1868
24H2072
24H2073
24K2823
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 3" X-Ray Detectable
Catalog Number: 200104
UDI codes:
(01)2 4026704 41752 4(17)260514(11)210514(10)21E1399
(01)2 4026704 41752 4(17)260520(11)210520(10)21E1505
(01)2 4026704 41752 4(17)260811(11)210811(10)21H2339
(01)2 4026704 41752 4(17)260812(11)210812(10)21H2329
(01)2 4026704 41752 4(17)260909(11)210909(10)21H2600
(01)2 4026704 41752 4(17)260910(11)210910(10)21H2601
(01)2 4026704 41752 4(17)261018(11)211018(10)21K3164
(01)2 4026704 41752 4(17)261210(11)211210(10)21M3734
(01)2 4026704 41752 4(17)270209(11)220209(10)22A0176
(01)2 4026704 41752 4(17)270315(11)220315(10)22C0662
(01)2 4026704 41752 4(17)270316(11)220316(10)22C0663
(01)2 4026704 41752 4(17)270426(11)220426(10)22D1059
(01)2 4026704 41752 4(17)270513(11)220513(10)22E1387
(01)2 4026704 41752 4(17)270623(11)220623(10)22F1952
(01)2 4026704 41752 4(17)271020(11)221020(10)22K3103
(01)2 4026704 41752 4(17)271108(11)221108(10)22K3275
(01)2 4026704 41752 4(17)280203(11)230203(10)23A0106
(01)2 4026704 41752 4(17)280405(11)230405(10)23D0797
(01)2 4026704 41752 4(17)280424(11)230424(10)23D0902
(01)2 4026704 41752 4(17)280530(11)230530(10)23E1181
(01)2 4026704 41752 4(17)280602(11)230602(10)23E1238
(01)2 4026704 41752 4(17)280808(11)230808(10)23H1837
(01)2 4026704 41752 4(17)290319(11)240319(10)24C0648
(01)2 4026704 41752 4(17)290808(11)240808(10)24G1866
(01)2 4026704 41752 4(17)291121(11)241121(10)24K2824
Lot/Batch Numbers:
21E1399
21E1505
21H2339
21H2329
21H2600
21H2601
21K3164
21M3734
22A0176
22C0662
22C0663
22D1059
22E1387
22F1952
22K3103
22K3275
23A0106
23D0797
23D0902
23E1181
23E1238
23H1837
24C0648
24G1866
24K2824
Pilling¿ Wecksorb Neurosponges (Cotton), 3/4" x 3/4" X-Ray Detectable
Catalog Number: 200105
UDI codes:
(01)2 4026704 41753 1(17)260615(11)210615(10)21F1809
(01)2 4026704 41753 1(17)271109(11)221109(10)22K3276
(01)2 4026704 41753 1(17)290821(11)240821(10)24H2068
(01)2 4026704 41753 1(17)290821(11)240821(10)24H2069
(01)2 4026704 41753 1(17)291105(11)241105(10)24K2769
Lot/Batch Numbers:
21F1809
22K3276
24H2068
24H2069
24K2769
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1" X-Ray Detectable
Catalog Number: 200106
UDI codes:
(01)2 4026704 41754 8(17)260517(11)210517(10)21E1400
(01)2 4026704 41754 8(17)260531(11)210531(10)21E1548
(01)2 4026704 41754 8(17)260811(11)210811(10)21H2330
(01)2 4026704 41754 8(17)260908(11)210908(10)21H2603
(01)2 4026704 41754 8(17)260910(11)210910(10)21H2602
(01)2 4026704 41754 8(17)261018(11)211018(10)21K3165
(01)2 4026704 41754 8(17)261213(11)211213(10)21M3735
(01)2 4026704 41754 8(17)270420(11)220420(10)22D1036
(01)2 4026704 41754 8(17)270516(11)220516(10)22E1388
(01)2 4026704 41754 8(17)271109(11)221109(10)22K3277
(01)2 4026704 41754 8(17)280203(11)230203(10)23A0107
(01)2 4026704 41754 8(17)280425(11)230425(10)23D0903
(01)2 4026704 41754 8(17)280605(11)230605(10)23E1239
(01)2 4026704 41754 8(17)280814(11)230814(10)23H1838
(01)2 4026704 41754 8(17)290503(11)240503(10)24D0988
(01)2 4026704 41754 8(17)290807(11)240807(10)24G1870
Lot/Batch Numbers:
21E1400
21E1548
21H2330
21H2603
21H2602
21K3165
21M3735
22D1036
22E1388
22K3277
23A0107
23D0903
23E1239
23H1838
24D0988
24G1870
Pilling¿ Wecksorb Neurosponges (Cotton), 3" x 3" X-Ray Detectable
Catalog Number: 200108
UDI codes:
(01)2 4026704 41755 5(17)271109(11)221109(10)22K3278
(01)2 4026704 41755 5(17)280126(11)230126(10)23A0108
Lot/Batch Numbers:
22K3278
23A0108
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1/2" Non X-Ray Detectable
Catalog Number: 200110
UDI code:
(01)2 4026704 41756 2(17)291128(11)241128(10)24L3000
Lot/Batch Number:
24L3000
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 3" Non X-Ray Detectable
Catalog Number: 200112
UDI codes:
(01)2 4026704 59940 4(17)260528(11)210528(10)21E1506
(01)2 4026704 59940 4(17)270803(11)220803(10)22G2233
(01)2 4026704 59940 4(17)271114(11)221114(10)22K3279
(01)2 4026704 59940 4(17)271114(11)221114(10)22K3280
Lot/Batch Numbers:
21E1506
22G2233
22K3279
22K3280
Pilling¿ Wecksorb Neurosponge Strips (Cotton), 3/8" x 6" X-Ray Detectable
Catalog Number: 200120
UDI codes:
(01)2 4026704 59938 1(17)260524(11)210524(10)21E1507
(01)2 4026704 59938 1(17)260727(11)210727(10)21G2034
(01)2 4026704 59938 1(17)260913(11)210913(10)21H2604
(01)2 4026704 59938 1(17)261124(11)211124(10)21L3508
(01)2 4026704 59938 1(17)270607(11)220607(10)22E1395
(01)2 4026704 59938 1(17)271107(11)221107(10)22K3281
(01)2 4026704 59938 1(17)291119(11)241119(10)24K2828
Lot/Batch Numbers:
21E1507
21G2034
21H2604
21L3508
22E1395
22K3281
24K2828
Pilling¿ Wecksorb Neurosponge Strips (Cotton), 1/2" x 6" X-Ray Detectable
Catalog Number: 200121
UDI codes:
(01)2 4026704 59939 8(17)260524(11)210524(10)21E1508
(01)2 4026704 59939 8(17)260729(11)210729(10)21G2179
(01)2 4026704 59939 8(17)260811(11)210811(10)21H2331
(01)2 4026704 59939 8(17)260913(11)210913(10)21H2605
(01)2 4026704 59939 8(17)261124(11)211124(10)21L3509
(01)2 4026704 59939 8(17)270208(11)220208(10)22A0177
(01)2 4026704 59939 8(17)270420(11)220420(10)22D1060
(01)2 4026704 59939 8(17)270601(11)220601(10)22E1396
(01)2 4026704 59939 8(17)271019(11)221019(10)22K3104
(01)2 4026704 59939 8(17)271110(11)221110(10)22K3329
(01)2 4026704 59939 8(17)271206(11)221206(10)22M3721
(01)2 4026704 59939 8(17)280126(11)230126(10)23A0110
(01)2 4026704 59939 8(17)280405(11)230405(10)23D0798
(01)2 4026704 59939 8(17)280810(11)230810(10)23H1839
(01)2 4026704 59939 8(17)280904(11)230904(10)23H2020
(01)2 4026704 59939 8(17)281027(11)231027(10)23K2511
(01)2 4026704 59939 8(17)290131(11)240131(10)24A0197
(01)2 4026704 59939 8(17)290228(11)240229(10)24B0441
(01)2 4026704 59939 8(17)290703(11)240703(10)24F1672
(01)2 4026704 59939 8(17)291107(11)241107(10)24K2829
Lot/Batch Numbers:
21E1508
21G2179
21H2331
21H2605
21L3509
22A0177
22D1060
22E1396
22K3104
22K3329
22M3721
23A0110
23D0798
23H1839
23H2020
23K2511
24A0197
24B0441
24F1672
24K2829
Pilling¿ Wecksorb Neurosponge Strips (Cotton), 1" x 6" X-Ray Detectable
Catalog Number: 200123
UDI codes:
(01)2 4026704 59940 4(17)260531(11)210531(10)21E1509
(01)2 4026704 59940 4(17)260913(11)210913(10)21H2606
(01)2 4026704 59940 4(17)261019(11)211019(10)21K3166
(01)2 4026704 59940 4(17)261124(11)211124(10)21L3510
(01)2 4026704 59940 4(17)261130(11)211130(10)21L3595
(01)2 4026704 59940 4(17)270202(11)220202(10)22A0058
(01)2 4026704 59940 4(17)270204(11)220204(10)22A0178
(01)2 4026704 59940 4(17)270413(11)220413(10)22B0458
(01)2 4026704 59940 4(17)270418(11)220418(10)22D1037
Lot/Batch Numbers:
21E1509
21H2606
21K3166
21L3510
21L3595
22A0058
22A0178
22B0458
22D1037
Pilling¿ Wecksorb Neurosponge Strips (Cotton), 1/2" x 6" Non X-Ray Detectable
Catalog Number: 200131
UDI codes:
(01)2 4026704 41758 6(17)260914(11)210914(10)21H2607
(01)2 4026704 41758 6(17)270420(11)220420(10)22D1061
(01)2 4026704 41758 6(17)270704(11)220704(10)22E1525
(01)2 4026704 41758 6(17)270914(11)220914(10)22J2716
(01)2 4026704 41758 6(17)271221(11)221221(10)22M3866
(01)2 4026704 41758 6(17)281005(11)231005(10)23J2342
Lot/Batch Numbers:
21H2607
22D1061
22E1525
22J2716
22M3866
23J2342
Distribution details:
1,481,700 Units (US)
7,000 Units (PA)
|
| FEI Number |
3005747797
|
Recalling Firm/
Manufacturer |
TELEFLEX LLC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
|
| For Additional Information Contact | Customer Service
866-3962111 |
|---|
Manufacturer Reason
for Recall | Due to out-of-specification, or potential out-of-specification, levels of endotoxins |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | On 05/07/2026, the firm sent via email and FedEx an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that firm is recalling Pilling Wecksorb Neurosponge lots due to out-of-specification/potential out-of-specification levels of endotoxin.
Medical facilities are instructed:
1. Immediately check inventory, cease use and immediately quarantine affected products.
2. For affected product, mark the applicable checkbox on the Acknowledgement Form and contact Customer Service:
a. Fax, including Attn: Customer Service , or email customer service.
OR
b. Using the online FSN Portal, complete the acknowledgement form virtually using the following link: https://fca.myteleflex.com/en/recall/000596
Note: Option b is only available to customers who received product directly from Teleflex.
3. If no affected product, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex.
4. A customer service representative will provide a Return Goods Authorization Number and instructions for the return of products. Teleflex/local dealer will issue a credit note upon receipt of the returned affected product.
Distributors
1. Provide copy of recall notice to all customers who received impacted product. Each customers is required to complete the Acknowledgement Form and return it to distributor.
2. Immediately check inventory, cease use and distribution, and immediately quarantine. Return all product in scope.
3. Confirm that field activity have been completed. Forward completed Acknowledgement Form to the e-mail address below.
Important - Please ensure only listed batch numbers in scope are listed. Acknowledgement form can be submitted virtually: https://fca.myteleflex.com/en/recall/000596
4. If affected products have been distributed outside of your country, notify Teleflex Customer Service by return email to the email address provided below.
For questions - Customer Service 1-866-396-2111, FAX: 1-855-419-8507 Email: Recalls@teleflex.com |
|---|
| Quantity in Commerce | 1488700 |
|---|
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = EFQ
|
|---|
|
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