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Medium RiskFDA Device
Medical Devices/Surgical Equipment

ECONO STERILE Medical Kits Recalled for Packaging and Sterility Breaches

Agency Publication Date: January 16, 2025
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Summary

Sklar Instruments is recalling 554,075 units of various ECONO STERILE brand medical procedure kits due to packaging defects that can compromise the sterile barrier. These kits include a wide variety of surgical instruments such as forceps, scissors, dilators, retractors, and suction tubes used in clinical settings. If the packaging is damaged or breached, the instruments may no longer be sterile, creating a potential risk of patient infection. To date, there have been no reports of injuries or incidents associated with this recall.

Risk

Using medical instruments that have lost their sterility can introduce bacteria or other contaminants into a patient's body during surgical or medical procedures. This poses a risk of infection or other complications to the patient. No injuries have been reported.

What You Should Do

  1. This recall affects a large volume of medical procedure kits and surgical instruments sold under the ECONO STERILE brand, including tools for ear, nasal, orthopedic, gynecological, and general surgical procedures.
  2. Check your medical inventory for products with the specific model numbers, lot codes, and Unique Device Identifiers (UDI) listed in the affected kit lists. See the Affected Products section below for the full list of affected codes.
  3. Immediately stop using any instruments or kits that match the recalled identifiers.
  4. Quarantine affected products to prevent their accidental use in clinical procedures.
  5. Contact Sklar Instruments or your medical distributor to arrange for the return, replacement, or correction of the affected medical kits.
  6. If you have health concerns regarding a procedure where these instruments may have been used, contact your healthcare provider for guidance.
  7. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this safety notice.

Your Remedy Options

📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ECONO STERILE Medical Procedure Kits (Ear Cleaning Tools)
Model / REF:
96-2273
96-2283
Lot Numbers:
SK-129
UDI:
50649111448735
50649111448780

Includes Buck Ear Currette and Billeau Ear Loop models.

Product: ECONO STERILE Medical Procedure Kits (Elevators)
Model / REF:
96-2483
96-2484
Lot Numbers:
FSS5
SK-115
UDI:
50649111449053
50649111492950

Includes Freer and Locke elevator models.

Product: ECONO STERILE Medical Procedure Kits (Trousseau Dilator)
Model / REF:
941-0191
Lot Numbers:
9249410191
UDI:
50649111232730

Used for tracheal procedures.

Product: ECONO STERILE Medical Procedure Kits (Sims Uterine Sound)
Model / REF:
96-2478
Lot Numbers:
SK-121
UDI:
50649111492615

For gynecological use.

Product: ECONO STERILE Medical Procedure Kits (Surgical Retractors)
Model / REF:
96-2201A
96-2203A
96-2207A
96-2208A
96-2209A
96-2210A
96-2241A
96-2242A
Lot Numbers:
SK-120
SK-130
SK-115
UDI:
50649111493100
50649111493094
50649111493117
50649111493124
50649111493155
50649111493162
50649111492820
50649111492837

Includes Weitlaner and Holzheimer retractor models.

Product: ECONO STERILE Medical Procedure Kits (Nasal Speculums)
Model / REF:
96-2236
96-2237M
96-2238
Lot Numbers:
SK-129
SK-130
SK-131
SK-133
UDI:
50649111439757
50649111439764
50649111439771

Vienna nasal speculum models.

Product: ECONO STERILE Medical Procedure Kits (Curette Excavator)
Model / REF:
941-1320
Lot Numbers:
7249411320
UDI:
50649111469907

General surgical instruments.

Product: ECONO STERILE Medical Procedure Kits (Nail and Tissue Nippers)
Model / REF:
96-2424A
96-2427
96-2666
96-2666A
96-2667
96-2671A
Lot Numbers:
SK-112
SK-131
SK-118
UDI:
50649111484504
50649111449008
50649111078918
50649111488120
50649111079090
50649111488113

For nail and tissue procedures.

Product: ECONO STERILE Medical Procedure Kits (Army, Senn, and Hohmann Retractors)
Model / REF:
96-2243
96-2243M
96-2267
96-2267A
96-2269A
96-2959
Lot Numbers:
SK-115
SK-116
SK-129
SK-117
SK-112
SK-118
UDI:
50649111493087
50649111448605
50649111448698
50649111487604
50649111487611
50649111493070

Surgical retractor tools.

Product: ECONO STERILE Medical Procedure Kits (Cement Spatula)
Model / REF:
96-2245M
Lot Numbers:
0724962245M
UDI:
50649111448612

Dental mixing utensil.

Product: ECONO STERILE Medical Procedure Kits (Vein Hooks)
Model / REF:
96-4020M
96-4021M
96-4022M
Lot Numbers:
SK-125
SK-128
UDI:
50649111476356
50649111476363
50649111476370

For venous procedures.

Product: ECONO STERILE Medical Procedure Kits (Towel Clips)
Model / REF:
96-2630
96-2636
Lot Numbers:
SK-128
SK-129
FSF14
UDI:
50649111072350
50649111073524

Backhaus towel clip models.

Product: ECONO STERILE Medical Procedure Kits (Scalpel Handle)
Model / REF:
96-3500M
Lot Numbers:
SK-125
UDI:
50649111149960

#3 Scalpel handle with metric scale.

Product: ECONO STERILE Medical Procedure Kits (Suction Tubes)
Model / REF:
96-4176
96-4177
96-5434
96-5435
96-5436
96-5437
96-5438
96-5439
96-5440
96-5492
96-5493
96-5494
Lot Numbers:
FSS4
FSS5
FSS6
UDI:
50649111493674
50649111493681
50649111493612
50649111493629
50649111493636
50649111493643
50649111493650
50649111493667
50649111493964
50649111481657
50649111481664
50649111481671

Includes Yankauer, Frazier, and Baron suction tube models.

Product: ECONO STERILE Medical Procedure Kits (Forceps - Comprehensive List)
Model / REF (149):
94-0286
94-0290
94-0291
941-0691
941-1414
94-1924
94-5034
94-6146
94-6616
96-2215A
96-2289
96-2293
96-2293A
96-2295A
96-2351
96-2386
96-2406
96-2408
96-2410
96-2412
96-2412A
96-2412M
96-2450M
96-2461
96-2462
96-2470A
96-2472A
96-2515
96-2515A
96-2532
96-2533
96-2533A
96-2533M
96-2534
96-2534A
96-2535A
96-2536
96-2536M
96-2537
96-2537A
96-2537M
96-2538
96-2539
96-2539A
96-2539M
96-2544
96-2545
96-2547
96-2547A
96-2548
Lot Numbers (64):
FSF21
SK-115
824940291
924940291
MST8
MST9
SK-122
FSF16
FSF22
SK-112
SK-135
SK-132
HSI
SK-116
HST21
FST21
FSF18
FSF24
FSF25
FSF5
FSF12
FSF26
FST9
FST6
FST10
FST11
FST12
FST20
0724962412M
0624962450M
FSF8
FSF14
FSF11
FSF17
FSF20
FSF23
FSF15
HSF8
HSF18
FSF10
0724962536M
0724962537M
FSF6
FSF13
SK-136
FSF9
FSF19
SK-133
SK-134
SK-131
UDI (149):
50649111094406
50649111095045
50649111095144
50649111307902
50649111464872
50649111345775
50649111040687
50649111215535
50649111287457
50649111487567
50649111439986
50649111440012
50649111487598
50649111493254
50649111440081
50649111440241
50649111035195
50649111035355
50649111035669
50649111035867
50649111487550
50649111027015
50649111464483
50649111440432
50649111464490
50649111487970
50649111487987
50649111050235
50649111487857
50649111053212
50649111053397
50649111487888
50649111215313
50649111478817
50649111492653
50649111488304
50649111054172
50649111220034
50649111054424
50649111219496
50649111221758
50649111054639
50649111054783
50649111487901
50649111225336
50649111056008
50649111056183
50649111056497
50649111236417
50649111056725

Extensive list of sterile surgical forceps including Kelly-Rankin, Halsted, and Roch-Pean models.

Product: ECONO STERILE Medical Procedure Kits (Blake Gallstone Forceps)
Model / REF:
96-4921A
Lot Numbers:
FSF20
UDI:
50649111493278

8 inch curved gallstone forceps.

Product: ECONO STERILE Medical Procedure Kits (Scissors - Comprehensive List)
Model / REF (89):
941-0918
941-1556
941-1613
94-1346
94-1925
94-4091
94-5692
94-6096
94-6097
96-1220
96-1221
96-1222
96-1224
96-1226
96-1228
96-2260
96-2261
96-2261A
96-2263A
96-2266
96-2433
96-2435
96-2437
96-2437A
96-2471
96-2492A
96-2494A
96-2495A
96-2496
96-2497
96-2499
96-2500
96-2500A
96-2502
96-2502M
96-2503
96-2503A
96-2504
96-2505
96-2505A
96-2506
96-2506M
96-2507
96-2507A
96-2511A
96-2512
96-2513
96-2514
96-2516
96-2517
Lot Numbers:
MSS8
FSS19
FSS23
FSS17
FSS8
FSS10
FSS20
FSK12
FSS5
FSS26
724961220
824961221
724961222
724961224
724961226
824961228
FSS21
HSS23
SK-112
FSF21
FSS24
HSI
724962471
0824962492A
SK-127
824962499
FSS7
FSS9
FSS11
FSS15
FSS16
SK-133
FSS22
FSS6
SK-124
60577
FSS13
SK-130
HSS8
HSS9
HSS17
HSS19
MSS10
FSS12
SK-129
SK-134
724962703
724962704
UDI (54):
50649111344174
50649111447752
50649111447912
50649111256613
50649111345966
50649111288454
50649111150126
50649111207509
50649111207622
50649111246096
50649111246140
50649111246287
50649111246546
50649111246867
50649111247178
50649111492622
50649111439870
50649111492646
50649111487536
50649111488359
50649111440357
50649111440371
50649111440395
50649111487543
50649111440524
50649111493933
50649111488229
50649111488236
50649111440630
50649111046924
50649111047341
50649111047617
50649111487581
50649111048041
50649111169289
50649111048225
50649111487574
50649111048386
50649111048577
50649111487628
50649111048799
50649111174535
50649111049017
50649111488243
50649111480704
50649111049819
50649111050006
50649111050129
50649111050402
50649111050594

Extensive list of surgical scissors including Iris, Metzenbaum, Mayo, Operating, and Lister Bandage models.

Product: ECONO STERILE Medical Procedure Kits (Schamberg Extractor)
Model / REF:
96-2395M
Lot Numbers:
SK-133
UDI:
50649111448896

Blackhead extractor tool.

Product: ECONO STERILE Medical Procedure Kits (Uterine and Cervical Curettes)
Model / REF:
96-4113
96-4144A
96-4145A
Lot Numbers:
SK-133
HSC21
UDI:
50649111492899
50649111492523
50649111492608

Includes Sims and Kevorkian biopsy curettes.

Product: ECONO STERILE Medical Procedure Kits (Vaginal Speculums)
Model / REF:
96-2603
96-2605
96-2607
96-2613
96-2615
96-2616
96-2617
96-3001
96-3002
Lot Numbers:
SK-119
UDI:
50649111067233
50649111067622
50649111067967
50649111068964
50649111069343
50649111069572
50649111069886
50649111133884
50649111134058

Includes Graves and Pederson speculum models.

Product: ECONO STERILE Medical Procedure Kits (Endocervical Speculum)
Model / REF:
96-4142A
Lot Numbers:
HSI
UDI:
50649111488014

Kogan endocervical speculum.

Product: ECONO STERILE Medical Procedure Kits (Uterine Dilators)
Model / REF:
96-0960
96-0961
96-0962
96-0963
96-0964
96-0965
96-0966
Lot Numbers:
FSS5
SK-119
UDI:
50649111474796
50649111474802
50649111474819
50649111474826
50649111474833
50649111474840
50649111474857

Hegar and Hank dilator models.

Product: ECONO STERILE Medical Procedure Kits (Biopsy Forceps)
Model / REF:
96-4134M
96-4137M
Lot Numbers:
SK-114
SK-116
UDI:
50649111492547
50649111492530

Mini Tisch and Oval biopsy forceps for gynecological use.

Product: ECONO STERILE Medical Procedure Kits (IUD Extractor)
Model / REF:
96-4146A
Lot Numbers:
SK-136
UDI:
50649111492707

Double hook extractor tool.

Product: ECONO STERILE Medical Procedure Kits (Infant Speculum)
Model / REF:
96-3814
Lot Numbers:
050824-01
UDI:
50649111455986

Alfonso infant eyelid speculum.

Product: ECONO STERILE Medical Procedure Kits (Strabismus Scissors)
Model / REF:
96-2540
96-2541
96-2542
96-2542M
Lot Numbers:
FSS8
FSS10
MSS10
UDI:
50649111054967
50649111055087
50649111055391
50649111440685

For eye surgery.

Product: ECONO STERILE Medical Procedure Kits (Iris Hook)
Model / REF:
96-2224A
Lot Numbers:
HSI
UDI:
50649111487932

For eye surgery.

Product: ECONO STERILE Medical Procedure Kits (Bone Rongeur)
Model / REF:
96-4780A
Lot Numbers:
HSI
UDI:
50649111488021

Lempert bone rongeur for orthopedic surgery.

Product: ECONO STERILE Medical Procedure Kits (Orthopedic Probe)
Model / REF:
94-5923
96-2361
Lot Numbers:
SK-115
SK-116
UDI:
50649111181663
50649111392601

Orthopedic probe with eye.

Product: ECONO STERILE Medical Procedure Kits (Needle Holders - Comprehensive List)
Model / REF:
96-2352A
96-2353
96-2355A
96-2356A
96-2358A
96-2417
96-2580
96-2581
96-2581A
96-2583
96-2583A
96-2585
96-2585A
96-2586
96-2587
96-2590
96-2591
96-2591A
96-2594
96-2595
96-2595A
96-2599
96-2659
96-2710
96-2711
96-2711A
96-2712
96-2740A
96-2741A
96-2742A
96-2745A
Lot Numbers:
HSI
SK-130
FSF12
FSF13
FSF17
FSF20
FSF22
FSF24
FSF26
FSS19
SK-112
FSF14
FSF21
SK-131
FSF7
FSF16
FSF18
FSF5
FSF19
FSF6
FSF10
60440
UDI:
50649111488151
50649111397996
50649111488144
50649111488137
50649111488168
50649111440272
50649111062696
50649111062955
50649111487796
50649111063266
50649111487833
50649111063549
50649111487895
50649111063877
50649111064010
50649111064577
50649111064799
50649111487826
50649111065437
50649111065642
50649111488052
50649111066342
50649111077669
50649111085664
50649111478886
50649111488069
50649111085916
50649111488274
50649111488281
50649111488298
50649111487949

Large collection of needle holders including Olsen-Hegar, Halsey, Baumgartner, and Mayo-Hegar models.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95946
Status: Active
Manufacturer: Sklar Instruments
Sold By: Medical distributors; Healthcare facilities; Specialty surgical suppliers
Manufactured In: United States
Units Affected: 30 products (25 units; 125 units; 0 units; 0 units; 75 units; 175 units; 0 units; 7730 units; 1050 units; 25 units; 1050 units; 300 units; 150 units; 150 units; 245015 units; 0 units; 252865 units; 25 units; 0 units; 475 units; 40 units; 75 units; 0 units; 0 units; units; 350 units; 25 units; 0 units; 2500 units; 41850 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.